Regulatory News from Across Asia-Pacific

The CDE of China published a draft of the Guidelines for Benefit-Risk Assessment Based on Multi-Regional Clinical Trial Data in Global....|The CDE of China published a draft of the Guidelines for Benefit-Risk Assessment Based on Multi-Regional Clinical Trial Data in Global....

These changes aim to enhance the certification process and ensure the quality and safety of cord sets and interconnection cord sets in China.|These changes aim to enhance the certification process and ensure the quality and safety of cord sets and interconnection cord sets in China.

The SAMR recently announced the implementation of mandatory product certification for electric vehicle power supply equipment, marking an....|The SAMR recently announced the implementation of mandatory product certification for electric vehicle power supply equipment, marking an....

The new standards for motor vehicle tires in China apply to both passenger car and truck tires. The main changes are intended|The new standards for motor vehicle tires in China apply to both passenger car and truck tires. The main changes are intended

The MARA has issued new veterinary drug registration guidelines aimed at strengthening the management of veterinary drug registrations...|The MARA has issued new veterinary drug registration guidelines aimed at strengthening the management of veterinary drug registrations...

One of the primary objectives of China's centralized procurement mechanism is ensuring that the medicines and medical consumables...|One of the primary objectives of China's centralized procurement mechanism is ensuring that the medicines and medical consumables...

...risks associated with segmented production and provide technical requirements for products such as Antibody-Drug Conjugates (ADCs).|...risks associated with segmented production and provide technical requirements for products such as Antibody-Drug Conjugates (ADCs).

The approval of Isobutylamido Thiazolyl Resorcinol demonstrates China’s commitment to balancing innovation with consumer safety…|The approval of Isobutylamido Thiazolyl Resorcinol demonstrates China’s commitment to balancing innovation with consumer safety…

The national standard "Diagnostic Techniques for Equine Rhinopneumonitis" has been published and is set to be implemented on June 1, 2025.|The national standard "Diagnostic Techniques for Equine Rhinopneumonitis" has been published and is set to be implemented on June 1, 2025.

The national standard titled "Diagnostic Techniques for Canine Distemper" has been published and is set to come into effect on June 1, 2025.|The national standard titled "Diagnostic Techniques for Canine Distemper" has been published and is set to come into effect on June 1, 2025.

On October 21, 2024, the NMPA of China provided an overview of the current status of pediatric IVD reagents in the country, highlighting...|On October 21, 2024, the NMPA of China provided an overview of the current status of pediatric IVD reagents in the country, highlighting...

The NMPA has released a draft of the ‘Good Manufacturing Practices for Medical Devices’, which is now open for public comment...|The NMPA has released a draft of the ‘Good Manufacturing Practices for Medical Devices’, which is now open for public comment...

On October 23, 2024, Cisema’s regulatory specialist Miriam Bandinelli shared valuable insights concerning China’s cosmetics market...

China water efficiency label updated on Nozzle implementation rules have been published by the National Development and Reform Commission, effective from January 1, 2025|China water efficiency label updated on Nozzle implementation rules have been published by the National Development and Reform Commission, effective from January 1, 2025

2024 IVD Reagents Clinical Trial Exemption Catalog draft has been announced by the CMDE on November 4, 2024, and opened for public consultation|2024 IVD Reagents Clinical Trial Exemption Catalog draft has been announced by the CMDE on November 4, 2024, and opened for public consultation

China priority acceptance service for innovative drugs marketing applications has been introduced by the CDE on October 24, 2024, and it came into effective from November 1, 2024.|China priority acceptance service for innovative drugs marketing applications has been introduced by the CDE on October 24, 2024, and it came into effective from November 1, 2024.

China’s NMPA has announced Interim regulations on the Administration of Designated Domestic Responsible Person for Foreign Drug Marketing License Holders|China’s NMPA has announced Interim regulations on the Administration of Designated Domestic Responsible Person for Foreign Drug Marketing License Holders

China domestic production of imported medical devices policy has been drafted and released by the National Medical Products Administration (NMPA) on November 4 ,2024.|China domestic production of imported medical devices policy has been drafted and released by the National Medical Products Administration (NMPA) on November 4 ,2024.

China medical device industry standards were issued by the National Medical Products Administration in July 2024.|China medical device industry standards were issued by the National Medical Products Administration in July 2024.

China cosmetics adverse reactions self-investigation report writing guidelines have been drafted and announced by the National Center for ADR Monitoring on November 8, 2024.|China cosmetics adverse reactions self-investigation report writing guidelines have been drafted and announced by the National Center for ADR Monitoring on November 8, 2024.